BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 4171438 · Received October 14, 2014

    Report

    Report Number
    2024168-2014-06699
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ADDITIONALLY, TWENTY SEVEN UNUSED, STERILE, REPRESENTATIVE PROGLIDE DEVICES WITH THE SAME PART NUMBER AS THE COMPLAINT DEVICE, LOT NUMBERS (40620K1 AND 40815K1) WERE RETURNED FOR EVALUATION. ALL UNUSED DEVICES PASSED VISUAL AND FUNCTIONAL TESTING. A CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLE. BASED ON A VISUAL INSPECTION AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICES, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT WAS REPORTED THAT THE PROGLIDE DEVICE WAS USED IN A CALCIFIED VESSEL. PER THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. THE DEVICE WAS REPORTED TO BE DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER PERCLOSE PROGLIDE DEVICE IS FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE MODERATELY CALCIFIED LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH TWO PROGLIDE DEVICES, USING A PRE-CLOSE TECHNIQUE, VIA A 6F SHEATH PRIOR TO A PERCUTANEOUS TRANSLUMINAL INTERVENTION WITH IMPELLA PROCEDURE. REPORTEDLY, CUFF MISSES OCCURRED WITH BOTH DEVICES. THE PERCUTANEOUS TRANSLUMINAL INTERVENTION WITH IMPELLA PROCEDURE WAS COMPLETED AND HEMOSTASIS WAS ACHIEVED BY APPLYING MANUAL ARTERIAL COMPRESSION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650683 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40815K1

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention SHEATH: 6F, 13F, ANGIOMAX